Clinical factors leading to lamotrigine prescription in bipolar outpatients: subanalysis of the SIN-DEPRES study.

BACKGROUND: The use of lamotrigine is a point of discrepancy among the diverse guidelines published on the management of bipolar disorder (BD). Evidence supporting the long-term efficacy is reasonably robust. Nonetheless, the effectiveness of lamotrigine in acute treatment is vigorously debated and it is unclear how this drug is used in routine clinical practice. This subanalysis of the SIN-DEPRES study was designed to understand the clinical profile of bipolar patients receiving lamotrigine. METHODS: In this prospective national multicenter study, 652 patients with clinically stable bipolar I and II disorder were recruited. Clinical assessments included sociodemographic and clinical data, the Modified Clinical Global Impression scale for BD (CGI-BP-M), the Hamilton Depression Rating Scale (HDRS), and prescriptions of psychotropic medications and their doses. RESULTS: By means of a logistic regression model, an association between receiving treatment with lamotrigine and the following clinical variables was found: number of past depressive episodes (O.R.=2.875, 95% CI: 1.203-6.869, p=0.018), depressive polarity of the most recent episode (O.R.=1.945, 95% CI: 1.267-2.985, p=0.002), severity in CGI-BD-M depression (O.R.=1.850, 95% CI: 1.215-2.817, p=0.004), bipolar II disorder diagnosis (O.R.=1.635, 95% CI: 1.078-2.482, p=0.021) and number of episodes per year (O.R.=1.310, 95% CI: 1.069-1.605, p=0.009). LIMITATIONS: Subanalysis of the SIN-DEPRES study with a cross-sectional design. CONCLUSIONS: The use of lamotrigine in clinical practice is in accordance with most of the guidelines, which support its use in patients with depressive predominant polarity and bipolar II disorder.

Quality of life and treatment satisfaction in Spanish epilepsy patients on monotherapy with lamotrigine or valproic acid.

BACKGROUND: Patients suffering from epilepsy have an impaired health related quality of life (HRQoL) because of seizures and treatment adverse events. Epilepsy affects differently both genders, due to hormonal influence in women. The aim of this study is to assess the impact on HRQoL and treatment satisfaction in epilepsy patients treated with stable doses of lamotrigine and valproic acid. METHODS: Observational cohort prospective study was conducted in 18 Spanish neurology sites. Patients with clinically stable partial or generalized epilepsy, already receiving lamotrigine or valproic acid on monotherapy, were assessed in two visits: baseline and at 6 months. Socio-demographic and clinical variables were recorded at baseline; HRQoL (QOLIE-10) treatment satisfaction and women image self-perception were assessed at both visits. Impact on HRQoL was assessed in both treatment arms overall and in the women subgroup. RESULTS: A total of 107 patients were evaluated; 53 (14 men, 39 women) on lamotrigine and 54 (27 men, 27 women) on valproic acid. Mean (SD) age was 30.4 (9.1) years and mean (SD) time since epilepsy diagnosis was 8 (8.1) years. Mean (SD) QOLIE-10 score at baseline was 73.9 (15.7) points (76.6 and 71.4 for lamotrigine and valproic, respectively). At follow up, patients reported better HRQoL on both lamotrigine (78.8 points) (p<0.05) and on valproic (72.4 points) in comparison with baseline. Women's HRQoL at follow up was better on the lamotrigine arm compared with valproic acid: 78.8 (12.8) vs. 70.3 (15.9) (p<0.05). Women on the lamotrigine arm declared higher satisfaction with treatment and higher disagreement with the different statements referred to a negative image self-perception. CONCLUSIONS: Chronic patients with epilepsy already treated with lamotrigine slightly improved HRQoL at 6 month follow up, whereas no significant changes were observed in the valproic acid group. Lamotrigine impact on patients' HRQoL seems to be even more positive in the subgroup of women.

A multicentre retrospective study of the clinical use of ropinirole in the treatment of Parkinson's disease: the ROPI-PARK study.

OBJECTIVES: To evaluate the use of the non-ergot dopamine agonist ropinirole (RPN) in patients with Parkinson's disease in Spain, and to examine its effectiveness and tolerability in both monotherapy and combination therapy. METHODS: Fifty-two investigators participated in this study. Patients receiving RPN under usual clinical care conditions in Spanish Neurology outpatient clinic settings were identified (n=643) out of these, a random sample of 423 clinical records of patients treated with RPN in the previous 18 months was selected. The endpoints analyzed were: percentage of patients remaining on treatment during the period of study (maintenance), reported adverse reactions and treatment withdrawal (tolerability), changes in symptoms' severity as assessed by the Clinical Global Impression-Improvement (CGI-I) scale (effectiveness), and start-to-end mean RPN dose. RESULTS: Patients were 68.6+/-9.7 years old (mean+/-SD) and 57.6% were male. RPN was administered as monotherapy (24%) or add-on treatment (76%). The mean maintenance dose was 9.54+/-5.34mg/day. Adverse reactions were reported by 28.6% patients, the most frequent being somnolence and sedation (9.2%), gastrointestinal symptoms (6.9%), increase in dyskinesia (5.9%), and orthostatic symptoms (3.8%). Treatment was withdrawn in 14.4% of patients, because of adverse reactions (5.9%), lack of efficacy (2.1%), change in treatment or clinical trial inclusion (1.9%) or other reasons (4.5%). Neurologists considered that improvement was achieved in 81.5% of patients, according to CGI-I scale. CONCLUSIONS: The low incidence of adverse reactions and low rate of treatment withdrawal observed in this study support the effectiveness and tolerability of RPN in the treatment of Parkinson's disease.

Validación de la versión española del cuestionario de calidad de vida en epilepsia QOLIE-10 / Validation of the Spanish version of the QOLIE-10 quality of life in epilepsy questionnaire

la propia enfermedad, circunstancias negativas como losefectos secundarios de algunos tratamientos, el miedo a laaparición imprevisible de crisis, la estigmatización y limitacionesen las actividades de la vida diaria. Así, se acepta queel control de las crisis es sólo uno de los aspectos del manejodel paciente, ya que el deterioro en el funcionamientocognitivo, físico y psicológico influyen igualmente en su calidadde vida. Es imprescindible disponer de instrumentos demedida que valoren de forma rápida y precisa los complejosaspectos englobados en el concepto de calidad de vida enlas personas con epilepsia. El objetivo de este estudio fuevalidar en población española el cuestionario de calidad devida relacionada con la salud (CVRS) específico para la epilepsia,QOLIE-10 (Quality of Life in Epilepsy Inventory-10), unaversión reducida de más fácil aplicación clínica que el QOLIE-31.Métodos. Estudio observacional, prospectivo, nacionaly multicéntrico, en el que participaron 21 neurólogos. Se incluyeronpacientes entre 18-50 años con epilepsia focal ogeneralizada, en monoterapia (lamotrigina/ácido valproico)y clínicamente estables. Se realizaron dos visitas: una basal yotra a los 6 meses. Se recogieron variables sociodemográficas,clínicas (años de evolución de la enfermedad, tratamientoanterior y actual y acontecimientos adversos) y sociales(QOLIE-31, QOLIE-10).Resultados. Se incluyeron 107 pacientes. La edad mediafue de 30,4 (desviación estándar [DE]: 9,1) años; 61,7%eran mujeres. El tiempo medio de evolución de la epilepsiafue de 8 (DE: 8,1) años. El 84,1% contestaron correctamentetodos los ítems (factibilidad). La medida de Kaiser-Meyer-Olkin fue de 0,822, con un valor asociado p<0,001 (validezde contenido) (AU)

Introduction. Epilepsy patients not only have todeal with the disease itself but also the side effects of sometreatments, fear about sudden occurrence of seizures,stigmatization, and restrictions in activities of daily living.For this reason, it is accepted that seizure control isonly one feature of the clinical management of epilepsy,since cognitive, physical and psychological deteriorationalso affects quality of life. It is essential to have measurementtools that rapidly and accurately evaluate the complexaspects included in the concept of quality of life inpersons with epilepsy. This study has aimed to validate thespecific Health-Related Quality of Life (HRQoL) questionnairefor epileptic patients, QOLIE-10 (Quality of Life in EpilepsyInventory-10), a reduced version having easier clinicalapplication than the QOLIE-31 in a Spanish population.Methods. Naturalistic, prospective, national andmulticenter study, in which 21 Spanish neurologists tookpart. Patients with partial or generalized epilepsy from18 to 50 years, who were under monotherapy with lamotrigineor valproic acid and clinically stables, were included.Two visits were carried out, one basal visit and a45 6, month follow-up visit. Sociodemographic, clinical (ti-me since diagnosis, previous treatment, current treatmentand perceived adverse events) and social variables(QOLIE-31, QOLIE-10) were collected.Results. A total of 107 patients were included. Meanage was 30.4 (desviation standard [DE]: 9.1) years and61.7 % were women. Mean time since epilepsy diagnosiswas 8 (SD: 8.1) years. A total of 84.1 % of the patientsanswered all the items correctly (feasibility). The Kaiser-Meyer-Olkin measure was 0.822, with an associated pvalue<0.001 (content validity). QOLIE-10 scores did notshow any relationship with the type of seizures (p>0.05),either globally or for its different domains (cross-sectionalvalidity) (AU)

[Validation of the Spanish version of the QOLIE-10 quality of life in epilepsy questionnaire]. / Validación de la versión española del cuestionario de calidad de vida en epilepsia QOLIE-10.

INTRODUCTION: Epilepsy patients not only have to deal with the disease itself but also the side effects of some treatments, fear about sudden occurrence of seizures, stigmatization, and restrictions in activities of daily living. For this reason, it is accepted that seizure control is only one feature of the clinical management of epilepsy, since cognitive, physical and psychological deterioration also affects quality of life. It is essential to have measurement tools that rapidly and accurately evaluate the complex aspects included in the concept of quality of life in persons with epilepsy. This study has aimed to validate the specific Health-Related Quality of Life (HRQoL) questionnaire for epileptic patients, QOLIE-10 (Quality of Life in Epilepsy Inventory-10), a reduced version having easier clinical application than the QOLIE-31 in a Spanish population. METHODS: Naturalistic, prospective, national and multicenter study, in which 21 Spanish neurologists took part. Patients with partial or generalized epilepsy from 18 to 50 years, who were under monotherapy with lamotrigine or valproic acid and clinically stables, were included. Two visits were carried out, one basal visit and a 6, month follow-up visit. Sociodemographic, clinical (ti-me since diagnosis, previous treatment, current treatment and perceived adverse events) and social variables (QOLIE-31, QOLIE-10) were collected. RESULTS: A total of 107 patients were included. Mean age was 30.4 (deviation standard [DE]: 9.1) years and 61.7% were women. Mean time since epilepsy diagnosis was 8 (SD: 8.1) years. A total of 84.1% of the patients answered all the items correctly (feasibility). The Kaiser- Myer-Olkin measure was 0.822, with an associated pvalue<0.001 (content validity). QOLIE-10 scores did not show any relationship with the type of seizures (p>0.05), either globally or for its different domains (cross-sectional validity). The mean score went from 73.9 (SD: 15.7) to 75.5 (SD: 14.9) between the two visits, equivalent to an increase of HRQoL of 1.6 (SD: 7.6) points (p=0.37) (longitudinal validity). A Cronbach's alpha coefficient of 0.811 was obtained (internal consistency). Interclass correlation coefficients were higher than 0.7 (reliability). In the overall score the effect size obtained was of 0.10 (responsiveness to change). CONCLUSIONS: The Spanish version of the QOLIE-10 has been shown to be feasible, valid, reliable and responsive to changes. The QOLIE-10 is a useful tool to measure HRQoL in usual clinical practice.

[A retrospective study of the effectiveness of lamotrigine in monotherapy for the treatment of epileptic seizures. The ERELMO study]. / Estudio retrospectivo de la efectividad de la lamotrigina en monoterapia para el tratamiento de crisis epilépticas. Estudio ERELMO.

INTRODUCTION: The efficacy and tolerability of lamotrigine (LTG) in monotherapy and in combination therapy have been demonstrated in clinical trials. The aim of the ERELMO study was to retrospectively evaluate the effectiveness and safety of LTG, as monotherapy in the control of epileptic seizures in routine clinical practice in Spain. PATIENTS AND METHODS: 446 clinical records were selected of patients with LTG treatment in the twelve months previously to the beginning of the study. The main endpoints retrospectively analyzed were effectiveness (percentage of patients with 50% or greater reduction in seizure frequency, improvement in seizure control, percentage of patients remaining-seizure free at 2, 6 and 12 months of LTG monotherapy), and safety (adverse event profile reported and treatment withdrawal). RESULTS: The mean age was 41 years old, 57.8% were women. LTG monotherapy treatment (mean maintenance dose was 217.2 mg/day) reduced mean seizure frequency as compared with the basal condition at different study time points (2, 6, 12 months; p < 0.0001). At the end of the study 77% of the patients were seizure free. Loss of treatment effectiveness was shown in 8.5% of patients. Adverse reactions were reported by 15% of patients, the most frequent being insomnia, somnolence, headache and rash. At the end of the study, 88.8% patients were still receiving LTG monotherapy. CONCLUSIONS: The present study supports the use of LTG monotherapy due to its effectiveness and good tolerability to promote treatment compliance in usual clinical conditions in patients with epilepsy.

Estudio retrospectivo de la efectividad de la lamotrigina en monoterapia para el tratamiento de crisis epilépticas. Estudio ERELMO / A retrospective study of the effectiveness of lamotriginein monotherapy for the treatment of epileptic seizures the erelmo study

La eficacia y la tolerabilidad de la lamotrigina (LTG), tanto en monoterapia como en politerapia, sehan demostrado en ensayos clínicos. El objetivo del estudio ERELMO fue evaluar retrospectivamente la efectividad y la seguridad de la LTG en monoterapia en el control de crisis epilépticas en condiciones de uso clínico habitual en España. Pacientesy métodos. Se seleccionó a 446 pacientes que recibieron tratamiento con LTG en los 12 meses previos a la inclusión en el estudio. Las principales variables estudiadas fueron la efectividad (disminución al menos de un 50% en el número de crisis,mejoría en el control de crisis mensuales y pacientes libres de crisis a los 2, 6 y 12 meses) y la seguridad (efectos adversos y retiradas del tratamiento). Resultados. Se evaluaron 446 historias clínicas (edad media: 41 años; 57,8% mujeres). La LTG enmonoterapia (dosis media: 217,2 mg/día) produjo una disminución de la media de crisis respecto al valor basal en los diferentes períodos de estudio (2, 6, 12 meses; p < 0,0001). Al finalizar el estudio, un 77% de pacientes estaba libre de crisis epilépticas.Se encontró pérdida de efectividad de la LTG en el 8,5% de los pacientes. El 15% de los pacientes presentó efectos adversos, los más frecuentes de los cuales fueron insomnio, somnolencia, cefalea y erupción cutánea. Al finalizar el estudio, el 88,8% de los pacientes continuaba en tratamiento con LTG en monoterapia. Conclusión. El presente estudio avala la utilización de LTG en monoterapia debido a su efectividad y buena tolerabilidad, que facilitan el cumplimiento del tratamiento en condiciones de uso clínico habitual en pacientes con epilepsia

The efficacy and tolerability of lamotrigine (LTG) in monotherapy and in combination therapy havebeen demonstrated in clinical trials. The aim of the ERELMO study was to retrospectively evaluate the effectiveness and safety of LTG, as monotherapy in the control of epileptic seizures in routine clinical practice in Spain. Patients and methods. 446clinical records were selected of patients with LTG treatment in the twelve months previously to the beginning of the study. The main endpoints retrospectively analyzed were effectiveness (percentage of patients with 50% or greater reduction in seizurefrequency, improvement in seizure control, percentage of patients remaining-seizure free at 2, 6 and 12 months of LTG monotherapy), and safety (adverse event profile reported and treatment withdrawal). Results. The mean age was 41 years old, 57.8% were women. LTG monotherapy treatment (mean maintenance dose was 217.2 mg/day) reduced mean seizure frequency as compared with the basal condition at different study time points (2, 6, 12 months; p < 0.0001). At the end of thestudy 77% of the patients were seizure free. Loss of treatment effectiveness was shown in 8.5% of patients. Adverse reactions were reported by 15% of patients, the most frequent being insomnia, somnolence, headache and rash. At the end of the study,88.8% patients were still receiving LTG monotherapy. Conclusions. The present study supports the use of LTG monotherapy due to its effectiveness and good tolerability to promote treatment compliance in usual clinical conditions in patients withepilepsy

[Quality of the health care to the epileptic patients in Spain]. / Calidad asistencial en epilepsia. Situación de la asistencia a los pacientes epilépticos en España.

INTRODUCTION: The objective of the study was to evaluate the quality of the health care to the epileptic patient in Spain including recently diagnosed patients, controlled patients and medically refractory patients. METHODS: Throughout years 2001-2002 a questionnaire of consensus was agreed by neurologists from surgical epilepsy units, epilepsy units, community hospitals and outpatient clinics. RESULTS: A total of 139 questionnaires were analysed. Only one third of the hospitals had a specialized epilepsy clinic. The longest waiting lists for diagnostic procedures were video EEG and Holter EEG, with 175 and 97.6 days, respectively. Clear differences between autonomous communities as far as availability of neurologists on duty, availability of diagnostic tests and number of epilepsy units are stated, existing, in general, more resources in the autonomous communities with health transferred before 2002 and Madrid. CONCLUSIONS: As much the lack of resources as the inequalities indicate that we are still far from the quality standards recommended by the International League Against Epilepsy (ILAE), lacking a suitable lanning that eliminates the inequalities and it so approaches us a system of assistance integrated in different levels as it is set out by the international scientific community.

Calidad asistencial en epilepsia. Situación de la asistencia a los pacientes epilépticos en España / Quality of the health care to the epileptic patients in Spain

Introducción. El objetivo de este estudio es conocer la realidad asistencial al paciente epiléptico en España y valorar la calidad de la asistencia en el paciente epiléptico de reciente diagnóstico, controlado y refractario al tratamiento. Métodos. A lo largo de los años 2001-2002 se realizó una encuesta cuyo contenido fue elaborado mediante consenso entre especialistas de neurología que procedían de unidades de cirugía de la epilepsia, consultas de epilepsia en hospitales de referencia y especialistas de hospitales comarcales y centros de especialidades. Resultados. Se recogieron 139 cuestinarios (76 % de los enviados). Un tercio de los hospitales dispone de consulta especifica dedicada a la epilepsia. Respecto a la disponibilidad de las pruebas (EEG) diagnósticas, el vídeo y el Holter electroencefalográficos soportan los mayores tiempos de demora, 175 y 97,6 días, respectivamente. Se constatan claras diferencias entre comunidades autónomas en cuanto a realización de guardias de neurología, pruebas diagnósticas disponibles y número de consultas especificas, existiendo, en general, más recursos en las comunidades autónomas con sanidad transferida antes de 2002 y Madrid. Conclusiones. Tanto las carencias como las desigualdades encontradas indican que estamos todavía lejos de los estándares de calidad recomendados por la International Ligue Against Epilepsy (ILAE), faltando una planificación adecuada que elimine las desigualdades y nos acerque a un sistema de asistencia integrada en diferentes niveles, tal y como se propone por la comunidad científica internacional

Introduction. The objective of the study was to evaluate the quality of the health care to the epileptic patient in Spain including recently diagnosed patients, controlled patients and medically refractory patients. Methods. Throughout years 2001-2002 a questionnaire of consensus was agreed by neurologists from surgical epilepsy units, epilepsy units, community hospitals and oupatient clinics. Results. A total of 139 questionnaires were analysed. Only one third of the hospitals had a specialiced epilepsy clinic. The longest waiting lists for diagnostic procedures were video EEG and Holter EEG, with 175 and 97,6 days, respectively. Clear differences between autonomous communities as far as availability of neurologists on duty, availability of diagnostic tests and number of epilepsy units are stated, existing, in general, more resources in the autonomous communities with health transferred before 2002 and Madrid. Conc1usions. As much the lack of resources as the inequalities indicate that we are still far from the quality standards recommended by the International League Against Epilepsy (ILAE), lacking a suitable lanning that eliminates the inequalities and it so approaches us a system of assistance integrated in different levels as it is set out by the international scientific community